Table 3.
Summary of AEs over the full study period (PUNCH CD3 safety population; N = 267)
| Through 6 months after blinded treatmenta | Through 6 months after open-label treatment | |||
|---|---|---|---|---|
| Blinded placebo (n = 87) | Blinded RBX2660 (n = 180) | Blinded placebo, open-label RBX2660 (n = 24) | Blinded RBX2660, open-label RBX2660 (n = 41) | |
| All AEs, n (%) | 39 (44.8) | 100 (55.6) | 14 (58.3) | 24 (58.5) |
| AEs by maximum severityb | ||||
| Mild | 9 (10.3) | 42 (23.3) | 6 (25.0) | 8 (19.5) |
| Moderate | 25 (28.7) | 47 (26.1) | 6 (25.0) | 10 (24.4) |
| Severe | 5 (5.7) | 10 (5.6) | 1 (4.2) | 5 (12.2) |
| Potentially life threatening | 0 | 1 (0.6)c | 1 (4.2) | 1 (2.4) |
| Discontinued because of AE | 0 | 1 (0.6)c | 0 | 2 (4.9) |
| Serious AEs | 2 (2.3) | 7 (3.9) | 1 (4.2) | 5 (12.2) |
| Deaths | 0 | 1 (0.6)c | 0 | 1 (2.4) |
AE adverse event, CDI Clostridioides difficile infection, IP investigational product
aTreatment failures are censored at the time of CDI recurrence
bAEs reported by maximum severity as assessed by investigator using Common Terminology Criteria for Adverse Events (CTCAE) criteria
cSame participant represented in each category